The Combination of Donepezil and Cognitive Training for Treating Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Clinical Global Index of AUD recovery
研究概览
简要总结
This is an open label feasibility trial to learn whether the combination of donepezil and cognitive remediation therapy (Donepezil + CRT) may improve neurocognitive functioning and decreasing alcohol use in Veterans with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment and preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at baseline and at 13-week follow-up.
详细描述
Donepezil is FDA approved for treatment of dementia and recent animal studies have suggested that it may reduce craving in rat models of alcohol use disorder. Investigators' previous studies of cognitive remediation therapy (CRT) with work therapy have shown efficacy with newly recovering Veterans with AUD compared with work therapy alone. The current study combines Donepezil and CRT in an open-label trial to learn whether the combination of Donepezil + CRT may improve neurocognitive functioning and decrease alcohol use in Veterans with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment and provide preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at baseline and at 13-week follow-up. Primary outcome variables will be a Clinical Global Index of AUD recovery and a Global Cognitive Composite of MCI related neurocognitive assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 21-80 years of age
- •Fluency in English and a 6th grade or higher reading level
- •Meets DSM-V criteria for a current Alcohol Use Disorder
- •Referred for the study within 30 days of detoxification or last substance use according to medical records
- •Willingness to attend follow-up assessments at 13 weeks
- •Willingness to submit to Breathalyzer screenings and Urine Toxicology screenings.
- •Meets MCI criteria with greater than 1.5 SD below pre-morbid IQ estimate or 1.5 SD below standard norms on at least 1 key neurocognitive MCI related variable (Learning and Memory, Delayed Recall, Executive Function, Working Memory).
排除标准
- •Lifetime diagnosis of a psychotic disorder, not induced by drug use.
- •Current prescribed treatment of opioids or benzodiazepines, which may affect new learning Involvement in a legal case that may lead to incarceration during study period
- •Residential plans that would interfere with participation
- •Medical illness that may significantly compromise cognition (e.g. Parkinson's, Alzheimer's, Huntington's Chorea, Moderate or greater TBI).
- •An uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training.
- •Pre-morbid IQ estimate below
- •Unstable housing or lack of commitment to staying within a geographic area that would make follow-up possible.
- •Unwillingness to provide contact information of someone who can help study staff contact the participant in the event that study staff are unable to maintain contact directly.
- •Allergy to Donepezil.
- •Unstable cardiovascular disease or unstable medical condition-clinically determined by a physician.
- •Imminent suicidal or homicidal risk.
- •Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential.
结局指标
主要结局
Clinical Global Index of AUD recovery
时间窗: 13 weeks
7-point likert scale of recovery
Global Composite T-Score of MCI related neurocognitive measures.
时间窗: 13-week
Measures of Learning and memory, delayed recall, working memory and executive. Higher scores indicate better functioning
次要结局
未报告次要终点
研究者
Morris Bell
Senior Research Career Scientist
VA Connecticut Healthcare System